Objective Measurements of Lens Opacification After Intravitreal Injections (MOC-IVT)

Objective Measurements of Lens Opacification After Intravitreal Injections (MOC-IVT)

The main hypothesis is the opacification of the lens would be increase by the IVT.

The opacification of the lens can be objectived by :

• the objective scatter index (OSI) on the OQAS device
• the average lens density (ALD) on the IOLMaster device.

Eligible patients will be followed at least 12 months after in intravitreal injection and the opacification of their lens is regularly controlled with OSI and ALD.

The objective is to study the dynamics of lens opacification in IVT-treated eyes evaluated by OSI for at least 1 year.

Study Overview

• Status: Withdrawn
• Conditions: Lens Opacification; Intravitreal Injections (IVT)
• Intervention / Treatment: Diagnostic test: Measurement of lens opacification

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with an indication for intravitreal injection (IVT) for medical condition.

Description

Inclusion criteria:

• An indication of an intravenous injection of a dexamethasone 700 μg (Ozurdex®) or anti-VEGF for at least one of the two eyes for macular edema or neovessels linked to DMLA, retinal venous occlusion, diabetic macular edema or posterior uveitis
• Phake patient, at least of the injected eye

Exclusion criteria:

- Pseudophakia of the injected eye

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Value of the OSI (Objective Scatter Index) in one year of follow-up after IVT	12 months

Collaborators and Investigators

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Actual): September 1, 2019
• Study Completion (Actual): September 1, 2019

Study Registration Dates

• First Submitted: May 24, 2019
• First Submitted That Met QC Criteria: May 24, 2019
• First Posted (Actual): May 28, 2019

Study Record Updates

• Last Update Posted (Actual): January 22, 2020
• Last Update Submitted That Met QC Criteria: January 17, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Cataract; objective scatter index (OSI); average lens density (ALD)
• Other Study ID Numbers: EBA_2019_9

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No